In re Ciprofloxacin Hydrochloride Antitrust Litigation

Amicus brief before the United States Court of Appeals for the Federal Circuit, in support of appellants and urging reversal of a decision by the United States District Court for the Eastern District of New York dismissing plaintiffs-appellants' federal antitrust claims on the ground that defendants' challenged patent settlement agreement was immunized by the patent laws. The case, filed by direct and indirect purchasers of the wide-spectrum antibiotic drug ciprofloxacin hydrochloride (“Cipro”), involves agreements between defendants Bayer AG and its U.S. subsidiary Bayer Corporation – manufacturer of Cipro and assignee of U.S. Patent No. 4,670,444 which claims the active ingredient in Cipro – and generic manufacturers Barr Laboratories, Inc., The Rugby Group, Inc., Hoechst Marion Roussel, Inc., and Watson Pharmaceuticals, Inc. Under the terms of those agreements (executed in January 1997), Bayer paid the generic companies approximately $398 million in exchange for their agreements not to manufacture any form of Cipro and for Barr’s agreement to terminate its challenge to Bayer's patent by converting its Abbreviated New Drug Application for a generic form of Cipro to permit Barr to market its generic drug only upon expiration of the ‘444 patent in December 2003. In its amicus brief, the Commission argues that the district court's ruling is not compelled by the patent laws, and it conflicts with fundamental antitrust principles.